Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-28 @ 12:03 AM
Study NCT ID:
NCT04451694
Status:
UNKNOWN
Last Update Posted:
2020-06-30
First Post:
2020-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nutritional Follow up After Hospital Discharge for Coronavirus Disease-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D055948', 'term': 'Sarcopenia'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 800}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-06-25', 'studyFirstSubmitDate': '2020-06-15', 'studyFirstSubmitQcDate': '2020-06-25', 'lastUpdatePostDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'nutritional evaluation', 'timeFrame': 'before Covid, at hospital discharge and between 7 and 45 days after discharge', 'description': 'weight'}, {'measure': 'nutritional evaluation', 'timeFrame': 'before Covid, at at the time of hospital admission, at the time of hospital discharge and between 7 and 45 days after discharge', 'description': 'BMI'}], 'secondaryOutcomes': [{'measure': 'muscle strenght', 'timeFrame': 'at the time of hospital admission and at the time of hospital discharge', 'description': 'hand grip'}, {'measure': 'food intake', 'timeFrame': 'at the time of hospital admission, at the time of hospital discharge', 'description': 'Caloric account'}, {'measure': 'food intake', 'timeFrame': 'between 7 and 45 days after discharge', 'description': 'self evaluation of food intake'}, {'measure': 'muscle strenght', 'timeFrame': 'between 7 and 45 days after discharge', 'description': 'self evaluation of muscle strenght'}, {'measure': 'biological nutritional status', 'timeFrame': 'at the time of hospital admission, at the time of hospital discharge', 'description': 'albuminemia transthyretinemia electrolytes dosage inflammation status'}, {'measure': 'anosmia', 'timeFrame': 'at the time of hospital admission, at the time of hospital discharge and between 7 and 45 days after discharge', 'description': 'anosmia and agueusia evolution'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['nutritional status', 'malnutrition', 'diet intervention', 'sarcopenia', 'muscle strength'], 'conditions': ['Covid-19']}, 'referencesModule': {'references': [{'pmid': '37739706', 'type': 'DERIVED', 'citation': 'Treuil M, Mahmutovic M, Di Patrizio P, Nguyen-Thi PL, Quilliot D. Assessment of dynapenia and undernutrition in primary care, a systematic screening study in community medicine. Clin Nutr ESPEN. 2023 Oct;57:561-568. doi: 10.1016/j.clnesp.2023.08.003. Epub 2023 Aug 5.'}, {'pmid': '34261689', 'type': 'DERIVED', 'citation': 'Quilliot D, Gerard M, Bonsack O, Malgras A, Vaillant MF, Di Patrizio P, Jaussaud R, Ziegler O, Nguyen-Thi PL. Impact of severe SARS-CoV-2 infection on nutritional status and subjective functional loss in a prospective cohort of COVID-19 survivors. BMJ Open. 2021 Jul 14;11(7):e048948. doi: 10.1136/bmjopen-2021-048948.'}]}, 'descriptionModule': {'briefSummary': "Coronavirus infection is responsible for muscle wasting (sarcopenia), especially during prolonged stays in intensive care. Sarcopenia, in its functional aspect also seems major in patients hospitalized for this infection, in non-ICU unit. Weight loss also appears to be significant, despite a prevalence of overweight and obesity in severe forms. Undernutrition in the obese patient is also possible (undernourished obese and sarcopenia obesity). Anosmia and dysgeusia participate in undernutrition by reducing energy intake. The rehabilitation of these patients requires nutritional support (increased protein intake) associated with progressive retraining to physical activity.\n\nAn early and proactive management procedure within Coronavirus disease-19 units has been implemented in conjunction with the Transversal Nutrition Unit (TNU). This nutritional care must be continued after discharge. Follow-up by teleconsultation or telephone consultation is put in place after the patient's discharge Primary Objective: Evaluation of nutritional status at the time of admission and discharge and home follow-up in outgoing patients from Coronavirus disease-19 Units Secondary objectives: Description of the evolution of food intake, diversity of food and coverage of needs Evaluation of the muscular strength of the wrist (by grip test in hospital) and on the arms and legs after return home (visual analog scale) Evolution of anosmia and dysgeusia (at the time of hospital admission, at the time of hospital discharge and at home) Level of physical training before infection (IPAQ) Description of the general state of health measured by the performance index - world health organization scale Description of nutritional prescriptions Description of the prevention measures and incidence of Inappropriate Refeeding Syndrome (IRS) Care needs assessments"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'complete survey, about 800 patients. No sample List of patients discharged from COVID Units', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Covid positive (RT-PCR)\n\nExclusion Criteria:\n\n* Unable to answer questions by telephone or teleconsultation directly or through a relative, minors under 16 years of age'}, 'identificationModule': {'nctId': 'NCT04451694', 'acronym': 'NutriCoviDom', 'briefTitle': 'Nutritional Follow up After Hospital Discharge for Coronavirus Disease-19', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Nutritional Follow up After Hospital Discharge for Coronavirus Disease-19', 'orgStudyIdInfo': {'id': '2020PI097'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Covid-19 unit outgoing patients', 'description': 'nutritional evaluation and intervention', 'interventionNames': ['Other: nutritional intervention']}], 'interventions': [{'name': 'nutritional intervention', 'type': 'OTHER', 'description': 'nutritional evaluation and intervention and orientation towards adapted care establishment', 'armGroupLabels': ['Covid-19 unit outgoing patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54500', 'city': 'Vandœuvre-lès-Nancy', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Didier Quilliot, Md PhD', 'role': 'CONTACT', 'email': 'quilliot.d@orange.fr', 'phone': '0684308721'}, {'name': 'marine Gerard, resident', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Quilliot', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}